Cardiac Arrest and Duration of Hypothermia Therapy

Duration of Hypothermia for Neuroprotection After Pediatric Cardiac Arrest

Protocol Description

Through this study, researchers will explore whether 24 or 72 hours of cooling is better to help prevent brain injury and improve the outcome for children who have suffered from cardiac arrest. Cooling has been shown to decrease the amount of brain injury that can occur after cardiac arrest in adults and in newborn babies with birth asphyxia (a lack of blood flow and oxygen to the fetus). Although it is not known whether body cooling is effective in children after cardiac arrest, cooling is recommended by the American Heart Association as a “consideration” for pediatric cases and has been used since 2002 by doctors in the pediatric/cardiac intensive care unit (PICU/CICU) of Children’s Hospital of Pittsburgh of UPMC.

Eligibility Criteria

Subject to certain exclusion criteria, this study is enrolling children between the ages of 1 week and 17 years who experienced cardiac arrest, received help with breathing and chest compressions to get a spontaneous heart rate by a health care worker, and remains unconscious in the PICU/CICU.Females: Ages 1 week to 17 years
Males: Ages 1 week to 17 years

Requirements

In this study, participants will be randomly assigned to receive either 24 or 72 hours of cooling to 90-93 F followed by gradual warming to regular body temperature. Researchers will compare the results of 1) blood and urine derived markers of brain injury, 2) results of brain magnetic resonance imaging and spectroscopy, and 3) safety markers. Using telephone or mail questionnaires, researchers will evaluate whether cooling has had an effect on patient outcome and quality of life at 6 months and 1 year.Visits: Occurs while patient is in the PICU/CICU
Duration: 12 months for follow-up

Status: Open for Enrollment

Source(s) of Support

Laerdal Foundation
National Institute of Neurological Disorders and Stroke